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…States, and release into domestic commerce, of any future shipments of foreign-manufactured API for use in compounding non-customized 17P except in certain specified instances.” FDA argued that the Complaint should…
In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order—Executive Order 14081—titled…
…announced that the U.S. District Court for the Northern District of Illinois, Eastern Division, granted the FTC’s request for a temporary restraining order on August 6, 2010, requiring the companies…
…for anti-competitive use of the Food and Drug Administration’s (FDA’s) citizen petition process to delay generic competition. The FTC sued Shire after the company exploited FDA’s petition process to an…
FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated…
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food…
…Advising and training Assistant United States Attorneys on prosecuting opioid offenses; Maintaining statistics on opioid prosecutions; and Developing and evaluating the strategy to combat the opioid epidemic. HPM Comments The…
The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. The Ryan Haight Act was…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…to this paragraph is exempt from licensure under this Act. Section two adds 32 MRSA §13799: § 13799. Consumer choice preserved Nothing in this chapter may be construed to prohibit:…
…ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60)…
…relationship must exist for a doctor to issue a prescriptions in the usual course of professional practice and that the doctor must have conducted a physical examination to establish such…
…categories of drugs – prescription and Over-the-Counter (“OTC”). FDA states in the notice that the Agency would like to “explor[e] the public health benefit of certain drugs being available BTC…
…price (ASP) plus 6% (under sequestration, the actual payment is ASP plus 4.3%). The 6% add-on payment is intended to help physicians and hospitals cover the costs of drug ordering,…